Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During ERCP

Pancreatic Diseases Clinical Trial

Official title:

Comparison Between Continuous Infusion and Intermittent Bolus Injection of Propofol for Deep Sedation During Endoscopic Retrograde Cholangiopancreatography: a Prospective Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01900938
• Other study ID #: 2012-055
• Status: Not yet recruiting
• Phase: N/A
• First received: May 29, 2013
• Last updated: July 16, 2013
• Start date: September 2013
• Est. completion date: May 2014

Study information

• Verified date: July 2013
• Source: Hanyang University
• Contact: Kyo-Sang Yoo, MD, PhD
• Phone: 82-31-560-2178
• Email: kyoo[@]hanyang.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare sedation efficiency, safety and satisfaction by both endoscopist, assistants, and the patients between continuous infusion and intermittent bolus injection of propofol for deep sedation during ERCP.

Description:

The patients undergone ERCP were randomly assigned to either continuous infusion of propofol (continuous group) or midazolam plus intermittent bolus injection of propofol (intermittent group) for deep sedation. In the continuous group, propofol was continuously administered via infusion pump and the doses were determined by sedation assistants monitoring the patients. In the intermittent group, a loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol was initially injected and repeated bolus injection of 20 mg of propofol was followed according to patients' sedation level. Sedation related parameters (total dose of propofol, induction/recovery time, patients' cooperation) and adverse events during the procedure were evaluated. Satisfaction scores by endoscopist, assistant, and patients and difficulty scores of maintaining the sedation by assistants were also graded after the procedure.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients undergone ERCP for biliary and pancreatic diseases

Exclusion Criteria:

• Comorbid conditions of ASA class 4-5

• Age under 18 years or over 90 years

• Pregnancy

• Past medication history of benzodiazepine or narcotics

• Known allergy to midazolam or propofol

• hypotension (systolic blood pressure <90 mmHg), hypoxemia (SaO2 <90%), or bradycardia (50/min) at baseline measurements

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Biliary Tract Diseases
• Pancreatic Diseases

Intervention

Procedure:
• Continuous infusion of propofol
Propofol is continuously administered intravenously via infusion pump starting with 20 mg/kg/hr and then titrated to about 5 mg/kg/hr according to patients' sedation level.
• Intermittent bolus injection of propofol
A loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol is initially injected and then repeated intermittent bolus injection of 20 mg of propofol is followed according to patients' sedation level.

Drug:
• Midazolam

• Propofol

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Guri Hospital	Guri	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction scores by endoscopist		30 minutes after the procedure	No
Secondary	Adverse events for sedation		1 day after the procedure	Yes
Secondary	Difficulty scores of maintaining the sedation		30 minutes after the procedure	No